Chronic Ischemic Heart DiseasePhase 2NCT03505346
68 Ga-NODAGA-E[c(RGDγK)]2: Positron Emission Tomography Tracer for Imaging of Angiogenesis in Ischemic Heart Disease
A Phase 2 study testing 68Ga-NODAGA-E[c(RGDyK)]2 in people with Chronic Ischemic Heart Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The aim is to examine the expression of αvβ3 integrin using a novel selective radiotracer in patients with chronich ischemic heart disease and investigate if it is a suitable tool for predicting myocardial recovery and thus prognosis after intervention. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Chronic Ischemic Heart Disease
- What is being tested?
- 68Ga-NODAGA-E[c(RGDyK)]2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2024to 1 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 50 years
- Patient with known chornic ischemic Heart disease admitted to Rigshospitalet to either PCI og CABG
Who cannot join
- No prior history of Heart surgery
- Not treated with anti-angiogenic medicine
- Subject with pacemaker, cochlear implant or insulin pump
- Pregnancy
- Lactation
- Severe claustrophobia
Show all 12Show fewer
- Severe obesity (weight above 140kg)
- Conversion from PCI to CABG
- If a subject is in the fertile age, a pregnancy test will be use prior to injection to the PET_tracer
- If a subject is having a severe allergic reaction to the PET-tracer, the person will be excluded for the rest of the trial
- If the PET-tracer is administered subcutaneous, the person will be excluded for the rest of the trial¨
- Type I or II diabetes
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Physiology, Nuclear Medicine and PET
Copenhagen, Capital Region, 2100
About this study
The aim is to examine the expression of αvβ3 integrin using a novel selective radiotracer in patients with chronich ischemic heart disease and investigate if it is a suitable tool for predicting myocardial recovery and thus prognosis after intervention.
Read the detailed description
Ischemic heart disease is worldwide the single most frequent cause of death. The number of patients surviving acute myocardial injury is increasing due to improved acute treatment. However, after the initial repair, the tissue undergoes a remodeling phase to compensate for the damaged area. This re-modeling phase can change the structure end geometry of the heart resulting in lower ejection fraction, leading to cardiac dysfunction, which eventually leads to heart failure. Ischemic heart disease is most commently caused by arteriosclerosis of the coronary artery.
If chronic ischemic heart disease is left untreated, it will lead to symptoms to the patient. These symptons occur when the myocardiel oxygen demand exceeds the oxygen provided, due to coronary occlusion.
If the heart suffers from ischemia, the tissue reacts strongly to the hypoxia. The body will as a compensatory mechanism create new vessel to provide the tissue with oxygen. This is known as the biological process of angiogenesis. This complex process involves different angiogenic and pro-fibrotic transcription factors that initiate the restoration of capillaries by sprouting from the existing endothelial cells in response to hypoxia.
Integrin αvβ3 is a transmembrane cell surface receptor that is markedly upregulated in states of angiogenesis. It facilitates migration and proliferation and thereby allowing cells to respond to extracellular environment. Integrin αvβ3 is thus a key player in the angiogenic process. The integrin αvβ3 has a binding site for an RGD peptide (Arg-Gly-Asp motif) and this can be targeted by PET tracers.
RGD-based PET tracers have been shown to accumulate at the site of myocardial necrosis in both human and animal studies. The uptake before interventions may correlate to recovery of cardiac function and thus serve as a prognostic marker after intervention.
- Conditions
- Chronic Ischemic Heart Disease
- Being tested
- 68Ga-NODAGA-E[c(RGDyK)]2
- Keywords
- Positron Emission Tomography, nuclear medicine, prognosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-NODAGA-E[c(RGDyK)]2Drug
Also called RGD-PET
200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 administered IV.
| Study group | Role | What they receive |
|---|---|---|
| percutanous coronary intervention(PCI) | Experimental | 200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 administered IV. two times. 14-21 days before intervention and 30-35 days after intervention Receives: Drug: 68Ga-NODAGA-E[c(RGDyK)]2 |
| Coronary artery bypass-graft(CABG) | Experimental | 200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 administered IV. two times. 14-21 days before intervention and 30-35 days after interventionintervention Receives: Drug: 68Ga-NODAGA-E[c(RGDyK)]2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate myocardial angiogenesis
Analysing change in uptake of 68Ga-NODAGA-E[c(RGDyK)]2 Positron Emission Tomography after intervention
Measured: 30-35 days
Secondary outcomes (3)
Correlation between 68Ga-NODAGA-E[c(RGDyK)]2 and myocardial perfusion
Correlation between uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and change in myocardial perfusion after intervention using Rubidium 82 Positron Emission Tomography
Measured: 30-35 days
Correlation between 68Ga-NODAGA-E[c(RGDyK)]2 and functional recovery
Correlation between uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and functional recovery using Magnetic Resonance after intervention
Measured: 30-35 days
Correlatino between 68Ga-NODAGA-E[c(RGDyK)]2 and viability
Correlation between uptake of 68Ga-NODAGA-E[c(RGDyK)]2 and viability using Flour-Deoxy-Glucose Positron Emission Tomography after intervention
Measured: 30-35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start1 Jan 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Bentsen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Andreas Kjær, MD, Study director, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03505346
- Sponsor's protocol ID
- EUDRA-CT: 2017-002712-14
- Status last verified
- Nov 2023
- First submitted
- 5 Mar 2018
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 68 Ga-NODAGA-E[c(RGDγK)]2: Positron Emission Tomography Tracer for Imaging of Angiogenesis in Ischemic Heart Disease
- ClinicalTrials.gov ID
- NCT03505346
- Acronym / sponsor ID
- EUDRA-CT: 2017-002712-14
- Conditions
- Chronic Ischemic Heart Disease
- Keywords
- Positron Emission Tomography, nuclear medicine, prognosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 23 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim is to examine the expression of αvβ3 integrin using a novel selective radiotracer in patients with chronich ischemic heart disease and investigate if it is a suitable tool for predicting myocardial recovery and thus prognosis after intervention.
Detailed description
Ischemic heart disease is worldwide the single most frequent cause of death. The number of patients surviving acute myocardial injury is increasing due to improved acute treatment. However, after the initial repair, the tissue undergoes a remodeling phase to compensate for the damaged area. This re-modeling phase can change the structure end geometry of the heart resulting in lower ejection fraction, leading to cardiac dysfunction, which eventually leads to heart failure. Ischemic heart disease is most commently caused by arteriosclerosis of the coronary artery.
If chronic ischemic heart disease is left untreated, it will lead to symptoms to the patient. These symptons occur when the myocardiel oxygen demand exceeds the oxygen provided, due to coronary occlusion.
If the heart suffers from ischemia, the tissue reacts strongly to the hypoxia. The body will as a compensatory mechanism create new vessel to provide the tissue with oxygen. This is known as the biological process of angiogenesis. This complex process involves different angiogenic and pro-fibrotic transcription factors that initiate the restoration of capillaries by sprouting from the existing endothelial cells in response to hypoxia.
Integrin αvβ3 is a transmembrane cell surface receptor that is markedly upregulated in states of angiogenesis. It facilitates migration and proliferation and thereby allowing cells to respond to extracellular environment. Integrin αvβ3 is thus a key player in the angiogenic process. The integrin αvβ3 has a binding site for an RGD peptide (Arg-Gly-Asp motif) and this can be targeted by PET tracers.
RGD-based PET tracers have been shown to accumulate at the site of myocardial necrosis in both human and animal studies. The uptake before interventions may correlate to recovery of cardiac function and thus serve as a prognostic marker after intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| percutanous coronary intervention(PCI) | Experimental | Drug: 68Ga-NODAGA-E[c(RGDyK)]2200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 administered IV. two times. 14-21 days before intervention and 30-35 days after intervention |
| Coronary artery bypass-graft(CABG) | Experimental | Drug: 68Ga-NODAGA-E[c(RGDyK)]2200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 administered IV. two times. 14-21 days before intervention and 30-35 days after interventionintervention |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age over 50 years
- Patient with known chornic ischemic Heart disease admitted to Rigshospitalet to either PCI og CABG
Key exclusion criteria (12 listed)
- No prior history of Heart surgery
- Not treated with anti-angiogenic medicine
- Subject with pacemaker, cochlear implant or insulin pump
- Pregnancy
- Lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-NODAGA-E[c(RGDyK)]2Also: RGD-PET200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 administered IV. | Drug | Coronary artery bypass-graft(CABG), percutanous coronary intervention(PCI) |
Primary outcome
To evaluate myocardial angiogenesis
Time frame: 30-35 days
Analysing change in uptake of 68Ga-NODAGA-E[c(RGDyK)]2 Positron Emission Tomography after intervention
3 secondary outcomes
Correlation between 68Ga-NODAGA-E[c(RGDyK)]2 and myocardial perfusion
Time frame: 30-35 days
Correlation between 68Ga-NODAGA-E[c(RGDyK)]2 and functional recovery
Time frame: 30-35 days
Correlatino between 68Ga-NODAGA-E[c(RGDyK)]2 and viability
Time frame: 30-35 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Kjær, MD study director
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 68Ga-NODAGA-E[c(RGDyK)]2 in people with Chronic Ischemic Heart Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simon Bentsen, MD (+4535451793, simon.bentsen.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate myocardial angiogenesis (time frame: 30-35 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.